A Patient-Spouse Intervention for Self-Managing High Cholesterol

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of a Patient Support Intervention for Statin Medication Adherence

NCT06972979

Medication Adherence

NOT_YET_RECRUITING NA

Controlling Hypertension Outcomes by Improved Communication & Engagement

NCT01134887

Hypertension Stroke

COMPLETED NA

A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)

NCT00092846

Hypercholesterolemia

COMPLETED PHASE3

Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization

NCT00903032

Acute Coronary Syndrome

COMPLETED NA

Influence of Intervention Methodologies on Patient Choice of Therapy

NCT01414751

Communication Hypercholesterolemia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Background/Rationale: Coronary heart disease (CHD) is the leading cause of death in the United States, resulting in more than 500,000 heart attacks and another 500,00 deaths per year. More than 80% of veterans have \> 2 risk factors for CHD, underscoring the need for intervention. One major modifiable risk factor for CHD is elevated low-density lipoprotein cholesterol (LDL-C). Despite the proven success of diet, exercise, and medication, LDL-C frequently is not at the optimum level, due in part to patient nonadherence. Therefore, interventions are needed to increase adherence, thereby lowering LDL-C.

Objectives: Objectives: We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. The primary hypothesis was that patients enrolled in a telephone-based, spouse-assisted intervention will experience a clinically meaningful 7% reduction in LDL-C. The secondary hypotheses were that patients who receive the intervention would show a significant increase in adherence to medication, diet, and exercise.

Methods: In a 3-year study, a randomized controlled trial compared a 10-month, telephone-based, spouse-assisted intervention to usual care. Married patients with above-goal LDL-C and their spouses were consented, completed a baseline assessment, and then were randomly assigned to the intervention or usual care arm. Month 1 involved an educational call delivered to patients and spouses. Months 2-10 (except month 6) involved monthly goal setting calls delivered to patients and calls focused on increasing social support to spouses. The patient phone call will always preceded the spouse phone call. At 6 and 11 months, LDL-C and adherence were re-assessed. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months. Descriptive statistics were computed for all study variables within each study arm. Mixed effects models were used to evaluate the intervention's effect on the primary and secondary outcomes at 11 months. We also calculated intervention cost.

Status: Enrollment began in Fall, 2007 and was completed in July of 2009.

Impact: Elevated LDL-C is a major risk factor for CHD, stroke, and peripheral vascular disease, all of which are common among veterans. The expected increase in prevalence of CHD over the next several decades will result in an increased burden for both veterans and the VA health care system. Despite the known risk of hypercholesterolemia, many veterans have suboptimal LDL-C levels. As the latest evidence and recommendations suggest that these goals should be even lower, interventions to assist patients to lower LDL-C increasingly will be needed. The VA considers the reduction of LDL-C an important goal, as indicated by the major effort of the Ischemic Heart Disease Quality Enhancement Research Initiatives (QUERI). This study is important because (1) it addresses a highly prevalent risk factor for CHD among veterans; (2) it proposes a potentially low-cost method for improving LDL-C levels, which in turn could reduce VA healthcare costs; (3) the intervention is practical and could be disseminated easily in the VA healthcare system if proven effective; and (4) this intervention provides a model for self-management of other chronic diseases, such as diabetes and hypertension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spouse-assisted intervention

Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse developed a plan to support patient goal achievement.

Group Type EXPERIMENTAL

spouse-assisted intervention

Intervention Type BEHAVIORAL

Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.

Usual care

Couples assigned to this arm received educational materials at baseline and usual care thereafter, with no contact from the study interventionist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spouse-assisted intervention

Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* veteran
* elevated baseline low-density lipoprotein cholesterol level
* married

Exclusion Criteria

* no telephone number;
* spouse unwilling to participate;
* patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent;
* hospitalized past 3 months;
* survival prognosis less than 1 year;
* active psychosis or dementia; no primary care physician at VA;
* no medical visit to VA in past year;
* enrolled in another study focusing on lifestyle changes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes